REG NASA NPR 8910 1 REV C-2011 Care and Use of Animals.pdf

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1、1NPR 8910.1CEffective Date: December 2, 2011Expiration Date: December 2, 2016NASA Procedural Requirements_COMPLIANCE IS MANDATORYSubject: Care and Use of AnimalsResponsible Office: Office of the Chief Health and Medical OfficerProvided by IHSNot for ResaleNo reproduction or networking permitted with

2、out license from IHS-,-,-2Table of ContentsPrefaceP.1 PurposeP.2 ApplicabilityP.3 AuthorityP.4 Applicable Documents and FormsP.5 Measurement/VerificationP.6 CancellationChapter 1. ResponsibilitiesChapter 2. Recordkeeping RequirementsChapter 3. Approval for Use of NASA Facilities and EquipmentChapter

3、 4. Space Flight ActivitiesChapter 5. Disposition of Research AnimalsChapter 6. SanctionsChapter 7. Vertebrate Animal Science ReviewAppendix A. DefinitionsAppendix B. AcronymsAppendix C. NASA Principles for the Ethical Care and Use of AnimalsAppendix D. Policy on Communication of Animal Health and W

4、elfare During NASA SpaceFlight MissionsAppendix E. Required Vertebrate Animal Scientific Review (VASR) Text for NASAResearch SolicitationsAppendix F. Optional Supporting Material for the Vertebrate Animal Science Review(VASR)Appendix G. Instructions for Vertebrate Animal Science Review Reviewers (VA

5、SR)DISTRIBUTION:NODIS_This Document Is Uncontrolled When Printed.Check the NASA Online Directives Information System (NODIS) Library to verify that this isthe correct version before use: http:/nodis3.gsfc.nasa.govProvided by IHSNot for ResaleNo reproduction or networking permitted without license fr

6、om IHS-,-,-3NASA management is committed to using live animals in Agency-supported research,testing, teaching, and hardware development activities only when necessary. Whenanimals are required, the Agency shall comply with all applicable laws, regulations,and guidelines and ensure that the “NASA Pri

7、nciples for the Ethical Care and Use ofAnimals“ (Appendix B) are incorporated in its programs, when applicable.PREFACEP.1 PURPOSEThis NPR delineates the responsibilities and implementing requirements for theAgencys use of animals in research, testing, teaching, and hardware developmentactivities, in

8、cluding such activities conducted in non-U.S. facilities and space flightvehicles.P.2 APPLICABILITYa. This NPR applies to NASA Headquarters and NASA Centers, including ComponentFacilities, the Jet Propulsion Laboratory, and to all activities involving animals fundedby or sponsored by NASA or conduct

9、ed in or on NASA facilities, aircraft, orspacecraft. Such activities include those conducted under a cooperative agreement orgrant, contract, reimbursable agreement, or other arrangement or agreement enteredinto by NASA and another Government agency, private entity, non-Federal publicentity, or fore

10、ign entity.b.This NPR does not apply to environmental monitoring activities that are covered byUnited States Fish and Wildlife Service permits, livestock, or domesticated animalsunder non-NASA control that are permitted to be at NASA Centers or Facilities forother than research purposes (e.g., cattl

11、e leases and guide dogs), nor does it apply toanimals used by NASA, contractors, or other agencies for law enforcement purposes.P.3 AUTHORITYNPD 8910.1, Care and Use of Animals.P.4 APPLICABLE DOCUMENTS AND FORMSa. Animal Welfare Act of 1966, as amended, 7 U.S.C. 2131 et seq.b. Health Research Extens

12、ion Act of 1985, as amended, Pub. L. 99-158, 99 Stat. 820(1985).Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-4c. Animal Welfare, 9 C.F.R., Ch. I, Subch. A, Pts. 1-4.d. Care and Use of Animals in the Conduct of NASA Activities, 14 C.F.R., Pt. 1232.

13、e. U.S. Department of Health and Human Services, “Public Health Service Policy onHumane Care and Use of Laboratory Animals“ (PHS Policy) (2002).f. National Research Council, “Guide for the Care and Use of Laboratory Animals“(Guide) (1996).g. United States Interagency Research Animal Committee, “U.S.

14、 GovernmentPrinciples for the Utilization and Care of Vertebrate Animals Used in Testing,Research, and Training“ (1985).h. Policy and Guidelines for the Use and Care of Animals in Space-borne Research, inCommittee on Space Research (COSPAR) Information Bulletin: Space ResearchToday, Number 169, Augu

15、st 2007.i. Council for International Organizations of Medical Sciences, “International GuidingPrinciples for Biomedical Research Involving Animals“ (1985).j. NPR 1440.6, NASA Records Management.k. NPR 1441.1, NASA Records Retention Schedules.l. NPD 8910.1B, Care and Use of Animals.m. Institutional A

16、nimal Care and Use Committee Guidebook, 2nd Edition, 2002,DHHS, NIH, Office of Laboratory Animal Welfare; Applied Research Ethics NationalAssociation.n. Occupational Health and Safety in the Care and Use of Research Animals, 1997,National Academy of Sciences Institute for Laboratory Animal Research.

17、P.5 MEASUREMENT/VERIFICATIONAdherence to this NPR will be measured through strict tracking of requirementsoutlined herein and detailed in NASA NPD 8910.1B, Care and Use of Animals. Ingeneral terms, for all NASA-sponsored research involving animals, the requirementsshall include verification of accre

18、ditation and certifications, regular monitoring ofresearch activities and sanctions imposed, and corrective actions taken.Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-5P.6 CANCELLATIONNPR 8910.1B, Care and Use of Animals, dated October 7, 2009./S/

19、Dr. Richard S. WilliamsProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-6Chapter 1. Responsibilities1.1 The NASA Chief Health and Medical Officer (CHMO) is the Authorized NASAOfficial (ANO) for the care and use of animals. The CHMO may delegate duties

20、 of theANO to a senior individual in the office of the CHMO. The ANO shall be responsiblefor:a. Implementing the provisions of this NASA Procedural Requirement (NPR) andensuring that all Agency programs and activities involving animals comply fully withall applicable laws, regulations, and guideline

21、s.b. Designating a NASA representative for the Interagency Research AnimalCommittee (IRAC).c. Establishing and maintaining mechanisms for obtaining timely information from theOffice of Laboratory Animal Welfare (OLAW) of all cases in which the assurance ofan institution involved in NASA research has

22、 been withdrawn by the Public HealthService (PHS); and notifying NASA Institutional Animal Care and Use Committees(IACUC), Center Directors, Institutional Officials (IOs), and Research and FlightProgram Managers of such revocations so that they can determine if NASA awardsinvolving the use of animal

23、s are affected and take appropriate actions.d. Reviewing all sanctions imposed by Center Directors or IACUCs to determine iffurther sanctions are warranted, or, at his or her discretion, initiating investigations ofalleged noncompliance with this NPR and imposing sanctions when warranted.e. Appointi

24、ng the NASA Chief Veterinarian, who shall report to the ANO.f. Establishing and maintaining mechanisms to notify the NASA Chief Veterinarian,NASA IACUCs, Center Directors, IOs, and Research and Flight Program Managers ofreports of noncompliance with the Animal Welfare Act (AWA), PHS, and this NPRtha

25、t are received from non-NASA institutions where animal research is supported byNASA.g. Designating a NASA representative(s) for the Committee on Space Research(COSPAR) Panel on the Care and Use of Animals in Space-borne Research.1.2 The NASA Animal Policy Review Board (APRB) shall be responsible for

26、 meetingin person at least once per year and convening via a teleconference at least once eachcalendar year to accomplish the following:a. Reviewing and reaffirming that animal research, testing, and training are activitiesnecessary for the achievement of NASA goals and objectives.Provided by IHSNot

27、 for ResaleNo reproduction or networking permitted without license from IHS-,-,-7b. Reviewing and reaffirming the “NASA Principles for the Ethical Care and Use ofAnimals;“ 1.2.3 reviewing animal care and use policies and procedures, issues, and thisNPR.c. Cooperatively developing common procedures,

28、guidance, training, documentation,and forms which provide uniform and progressive application of professionallyaccepted standards at all NASA Centers involved in animal care and use activities.d. Reviewing each Centers Animal Care and Use Program at least once annually,through a review of the Center

29、s semiannual IACUC reports and other information asneeded.e. Coordinating the Centers Animal Care and Use Handbooks, IACUC ReferenceManuals, Animal Care and Use Protocol Form, and Animal Care and Use StandardOperating Procedures Workbooks to maximize commonality.f. Exchanging information regarding i

30、ssues and practices pertaining to animal care anduse.g. Recommending changes in NASA policies and procedures to the ANO and CenterDirectors, as appropriate.h. Serving as a source of expertise and advocacy on animal care and use issues for theANO, IACUCs, and NASA management.i. Assisting the ANO in d

31、eveloping responses to public, organizational, and legislativeinquiries and comments about NASA animal activities.1.3 The NASA Flight Animal Care and Use Panel (NFACUP) shall be responsible forthe following:a. Reviewing and providing policy concurrence on all protocols using animals that areassociat

32、ed with space flight activities supported by NASA. No NASA-supported spaceflight activity using animals will be conducted without such review and concurrenceby the NFACUP. The NFACUP may disapprove animal activities, but may notapprove an activity related to the care and use of animals if the activi

33、ties have not beenapproved by the appropriate Center IACUC.b. Providing Agency animal care and use policy approval for space flight activities.c. Providing assurance to the ANO that all animal research conducted in space flightmeets the requirements of all applicable Federal regulations, and that a

34、comprehensiveProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-8review of benefits and risks has been completed.d. Assuring NASA compliance with the COSPAR “Policy and Guidelines for the Useand Care of Animals in Space-borne Research.“1.4 Center Direct

35、ors shall be responsible for the following:a. Signing the Centers Animal Welfare Assurance, making a commitment on behalf ofthe Center that the requirements of this NPR will be met. Center Directors maydelegate authority for the day-to-day management of their Centers Animal Care andUse Program, but

36、they retain the ultimate responsibility for ensuring compliance withthe AWA, PHS Policy, the Guide, and this NPR at their Centers. In addition, onlyCenter Directors may appoint personnel to the IACUC.b. Serving as the Centers IO or delegating, in writing, an IO who meets therequirements of the PHS P

37、olicy and AWA to perform the following:(1) Establishing and supervising the functioning of their Centers IACUC. Thisresponsibility may be accomplished through the use of another Centers IACUC via aformal inter-Center agreement.(2) Signing and submitting to OLAW the AWA, committing the Center to ther

38、equirements of the PHS Policy and this NPR in all Center activities involvinganimals. Providing copies of the approved AWA, OLAW letter of approval, and anyOLAW correspondence to the ANO.(3) Approving and signing the application for Association for Assessment andAccreditation of Laboratory Animal Ca

39、re (AAALAC) International Accreditation andthe annual AAALAC International reports. Providing copies of the AAALACInternational Accreditation letter, the annual reports, and any correspondence fromAAALAC International to the ANO.(4) When applicable, approving the annual report to the U.S. Department

40、 ofAgriculture (USDA) and providing copies of the report and any comments fromUSDA to the ANO.(5) Deciding and administering sanctions in cases of noncompliance with this NPR, inaccordance with the AWA, its implementing regulations, PHS Policy, and NASApersonnel policies; and notifying appropriate f

41、unding officials and the ANO.(6) Providing the ANO with copies of all IACUC minutes and reports.1.5 The NASA Chief Veterinarian shall be responsible for the following:Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-9a. Coordinating veterinary and ani

42、mal care activities across NASA institutions. Inaccomplishing this responsibility, the NASA Chief Veterinarian is specificallyauthorized to halt any animal activity he or she believes to be noncompliant withapplicable laws, regulations, this NPR, and approved protocols. Following halting ofany activ

43、ity, the NASA Chief Veterinarian will initiate action, including IACUC re-review, to resolve the situation.b. Guiding, as Chairperson, the activities of the APRB.c. Advising the ANO on any aspect of the Agencys Animal Care and Use Program.d. Representing NASA in the external Laboratory Animal Scienc

44、e community andassociations.e. Participating in the development, review, and approval of requirements for allanimal facilities and equipment for flight as related to animal care and use.f. Maintaining coordination with the International Council for Laboratory AnimalScience (ICLAS) and COSPAR.g. Info

45、rming international entities and individuals about the technical requirements inaccordance with U.S. laws, regulations, guidelines, standards, and this NPR. This willinclude information regarding the requirements and constraints for flight animalresearch activities.h. Serving as the Chair of the NFA

46、CUP.i. Reviewing all material associated with a proposal that would otherwise be funded,but originally coded as “unacceptable” during the Vertebrate Animal Science Review(Chapter 7), and making a determination if it can be deemed “acceptable.”1.6 IACUC shall be responsible for the following:a. Perfo

47、rming responsibilities in accordance with provisions given in the AnimalWelfare Act, its implementing regulations, PHS Policy, and the Guide.b. The IACUC at the Ames Research Center (ARC) is charged with reviewing allspace flight activities and any supporting ground-based activities.c. When animals

48、are housed at a NASA Center (host Center), the host Centers IACUCis responsible for their care and use and for reviewing, approving, or disapprovingthose parts of proposals that call for the use of the Centers facilities housing theProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-10animals.d. Although in-flight spacecraft may contain facilities that are by definition “AnimalFacilities,“ it is recognized that IACUC inspection of